Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5935](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5935) → BYT — Ventilator, External Body, Negative Pressure, Adult (Cuirass)

# BYT · Ventilator, External Body, Negative Pressure, Adult (Cuirass)

_Anesthesiology · 21 CFR 868.5935 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT

## Overview

- **Product Code:** BYT
- **Device Name:** Ventilator, External Body, Negative Pressure, Adult (Cuirass)
- **Regulation:** [21 CFR 868.5935](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5935)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Life-sustaining:** yes

## Identification

An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 21)

Showing 20 most recent of 21 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K082657](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K082657.md) | RTX RESPIRATOR | Medivent Limited | Oct 8, 2008 | SESE |
| [K072290](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K072290.md) | PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS | Dima Italia Srl | May 29, 2008 | SESE |
| [K924341](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K924341.md) | HAYEK OSCILLATOR(TM) | Respironics, Inc. | Jul 21, 1993 | SESE |
| [K910947](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K910947.md) | NEV-10 NEGATIVE PRESSURE VENTILATOR | Lifecare Services, Inc. | Jun 3, 1991 | SESE |
| [K905530](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K905530.md) | PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | Mar 1, 1991 | SESE |
| [K902764](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K902764.md) | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM | J. H. Emerson Co. | Nov 19, 1990 | SESE |
| [K903745](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K903745.md) | THE HAYEK OSCILLATOR | Flexco Medical Instruments | Nov 9, 1990 | SESE |
| [K902300](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K902300.md) | EASY BREATHER MODEL 100 ACCESSORIES | Progressive Productions , Ltd. | Jul 19, 1990 | SESE |
| [K895849](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K895849.md) | RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM | Respironics, Inc. | Dec 22, 1989 | SESE |
| [K894649](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K894649.md) | EMERSON 33-CR CHEST RESPIRATOR | Emerson Intl. Co. | Oct 13, 1989 | SESE |
| [K893213](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K893213.md) | EASY BREATHER MODEL 100 | Progressive Productions , Ltd. | Aug 4, 1989 | SESE |
| [K881808](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K881808.md) | EMERSON CHEST RESPIRATOR, MODEL 33-CRE | J. H. Emerson Co. | Aug 4, 1988 | SESE |
| [K881689](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K881689.md) | LINDLEY II RESUSCITATOR | Lindley Resuscitator, Inc. | Jul 8, 1988 | SESE |
| [K863300](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K863300.md) | Q101 DIAGNOSTIC SPIROMETER | Quinton, Inc. | Nov 13, 1986 | SESE |
| [K860692](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K860692.md) | PTR MK II VENTILATOR | Bear Medical Systems, Inc. | May 21, 1986 | SESE |
| [K840885](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K840885.md) | LAKEVILLE BODY VENTILATOR | Edwards Ventilator Co. | Jul 12, 1984 | SESE |
| [K841090](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K841090.md) | VENTILATOR EXTERNAL BODY NEGATIVE PRESS | Porta-Lung Co. | May 30, 1984 | SESE |
| [K832176](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K832176.md) | NEGATIVE PRESSURE CHEST RESPIRATOR PUMP | J. H. Emerson Co. | Sep 12, 1983 | SESE |
| [K813326](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K813326.md) | TROCKI BODY VENTRILATOR | L.T.D. 3 Co. | Dec 22, 1981 | SESE |
| [K792673](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K792673.md) | CAM-10 CUIRASS SHELL | Lifecare Services, Inc. | Jan 11, 1980 | SESE |

## Top Applicants

- J. H. Emerson Co. — 3 clearances
- Lifecare Services, Inc. — 3 clearances
- Progressive Productions , Ltd. — 2 clearances
- Respironics, Inc. — 2 clearances
- Bear Medical Systems, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT)

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